Phase 4 N=24 Randomized Quadruple-blind Treatment

Optimizing Local Anesthetic Concentration for Continuous Popliteal-Sciatic Nerve Blocks

Relatively Healthy Volunteers

Bottom Line

View on ClinicalTrials.gov: NCT01898689 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2021

Primary outcome: Primary: Maximum Tolerance to Transcutaneous Electrical Stimulation — 27.0; 26.9 mA (milliamperes) — p=0.02

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Ropivacaine 0.1% (Drug); Ropivacaine 0.4% (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of California, San Diego
Primary completion: Nov 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Maximum Tolerance to Transcutaneous Electrical Stimulation	23; 22.5; 19; 20; 18; 19	—
SECONDARY Maximum Tolerance to Transcutaneous Electrical Stimulation	23; 22.5; 19; 20; 18; 19	—
SECONDARY Percent of Maximum Voluntary Isometric Contraction Baseline (Quadriceps Femoris)	100; 100; 90; 98; 8.1; 8.1	—

Summary

A continuous peripheral nerve block-also termed "perineural local anesthetic infusion"-involves the insertion of a tiny tube (a "catheter") through the skin and adjacent to a peripheral nerve, followed by local anesthetic (numbing medicine) administration via the catheter, providing pain control following surgery. Continuous peripheral nerve blocks may be provided in the hospital setting, but the use of lightweight, portable pumps permits infusion at home as well. However, it remains unknown if the concentration of the local anesthetic influences the block effects; or, is it rather simply the total dose of medication that is important. If it is the latter, then the concentration of local anesthetic could be increased, allowing a decreased basal infusion rate, which would allow patients at home to receive twice the duration of potent pain control since their infusion pump local anesthetic reservoir would last twice as long as current practice. In addition, if one concentration/dose combination results in less muscle weakness, but with at least equivalent analgesia, then the risk of falling might be decreased as well. The investigators will test the hypothesis that providing ropivacaine at different concentrations and rates (0.1% at 8 mL/hour vs. 0.4% at 2 mL/hour)-but at an equivalent total basal (8 mg/hour)-produces comparable effects when used in a continuous popliteal-sciatic nerve block.

Eligibility Criteria

Inclusion Criteria

age ≥ 18 years
willing to have bilateral femoral perineural catheters placed with a subsequent ropivacaine infusion and motor/sensory testing for 6 hours, requiring an overnight stay in the UCSD GCRC/CTRI to allow dissipation of local anesthetic infusion effects by the following morning

Exclusion Criteria

current daily analgesic use
opioid use within the previous 4 weeks
any neuro-muscular deficit of either femoral nerves and/or quadriceps muscles
morbid obesity [weight > 35 kg/m2]
pregnancy (as determined by a urine pregnancy test prior to any study interventions)
incarceration

We expect to recruit a maximum of 30 healthy volunteers; with a target goal of 24 for the analysis. Selection for inclusion will not be based on gender, race, or socioeconomic status. The study population of interest includes men and women of all races and socioeconomic status. There will be no participants from vulnerable populations, such as pregnant women, children, or prisoners.

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Data sourced from ClinicalTrials.gov (NCT01898689). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.